An emerging body of evidence is showing psychedelics as promising treatments for mental health conditions, and psychiatry needs to be prepared for their arrival, say researchers.
Recent years have seen an increasing amount of scientific evidence pointing to the potential of psychedelics as treatments for mental health conditions such as anxiety, depression, and PTSD. So far, this evidence has led countries such as Australia, Canada, and the US to allow special access to these medicines for select patients.
In particular, MDMA and psilocybin have produced robust results – now in Phase III trials – that show their efficacy for PTSD and treatment-resistant depression, respectively.
The developments around these two substances may lead to their approval as licenced medicines in the near future, with Lykos Therapeutics MDMA-assisted therapy for PTSD already receiving US Food and Drug Administration (FDA) acceptance and priority review for a New Drug Application (NDA), for example.
In a new article published in the British Journal of Psychiatry, researchers emphasise the need for the psychiatry profession to prepare for this possible outcome, and discuss how health systems might respond to these developments.
The authors write: “Given the rapidly emerging body of evidence of efficacy for psilocybin and MDMA, people’s great need for innovative treatments and the move towards approval in some countries before licences are awarded, it seems likely that these two drugs will become a part of psychiatric practice for many in the foreseeable future. The psychiatry profession and practising psychiatrists need to prepare for this.”
Supporting patient access
Medicines must undergo rigorous, double-blind randomised controlled trials (RTCs) to reach patients under approved licensing.
However, the authors highlight that this model poses challenges due to the high cost of trials, commercial incentives for indication testing, and socioeconomic/demographic factors impacting decisions on where a company makes a licensing application – such as population size and income.
This can mean that cancer treatments are prioritised over physiatric treatments, for example, and can lead to low- and middle-income countries waiting decades to gain access to new medicines.
The researchers suggest that off-license administration may provide a solution.
“Already psychiatrists in many countries are using ketamine ‘off licence’ to treat people with resistant depression. There is now comparable evidence of safety and efficacy for psilocybin and MDMA to allow, with the patients’ informed consent, competent clinicians to try them out ‘off licence’ as well as in severe illnesses when other treatments have failed,” write the authors.
“One of the main arguments from patients and their carers is the distress that they cannot access treatments of proven efficacy until a company chooses to market them; these people are totally disempowered. In Australia, the issue of drug supply outside the usual drug company medicine marketing model was solved by a charity sourcing the medicines from accredited manufacturers. This model could be used elsewhere.”
The authors also highlight that ensuring patient access to psychedelics will need a country-by-country approach, taking into consideration the unique challenges of each place.
Using the UK as an example, they highlight that the Advisory Council on the Misuse of Drugs (ACMD) “appear to be acting under the misperception that a marketing authorisation generated by a pharmaceutical company is necessary to change the Schedule 1 status of these compounds in the Misuse of Drugs Regulations.”
However, the UK’s Chief Medical Officer confirmed there was ample real-world evidence to support the legalisation of medical cannabis in 2018.
“There is now indubitably better evidence for psilocybin and MDMA in their respective Australian-approved indications than there was then for medical cannabis,” the authors write, suggesting regulatory controls for psychedelics such as a register of practitioners and supervised data collection for efficacy and adverse effects.
Training psychedelic psychiatrists
While scientific data may be mounting up and regulation changes are slowly creeping in across the globe, the roll-out of psychedelic therapies will also depend on having trained psychedelic therapists.
Lack of education and training has resulted in hesitation from NHS practitioners to prescribe medical cannabis, the authors highlight, so systematic training and relevant education will be vital if psychedelic medicines are to reach patients.
“By utilising innovative technologies, many of the educational and administrative tasks can be undertaken remotely, and we can learn from other countries, such as Australia, as to how to coordinate the delivery of excellent treatment,” the authors write.
“It is up to the gamut of professionals and organisations – for example, Royal College of Psychiatrists, the Chief Medical Officer, ACMD and other groups, to take the initiative early.”
The authors also suggest that the UK should establish a working group to explore the implementation of psychedelic therapies.
“We need to be ready for a change in the law which would signal a turning point in the provision of better treatment for some of the most incapacitating illnesses in medicine,” the authors conclude.
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